Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial

doi:10.1136/bmjopen-2023-075570

. 2023 Oct 3;13(10):e075570.

doi: 10.1136/bmjopen-2023-075570.

Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial

Leanne Sakzewski¹, Sarah Elizabeth Reedman², Catherine Elliott^{3

4}, Jenny Ziviani⁵, Iona Novak⁶, Stewart Trost^{7

8}, Annette Majnemer⁹, Tracy Comans¹⁰, Keiko Shikako⁹, Robert S Ware¹¹, Lynda McNamara¹², Sian Williams^{3

13}, Syed Afroz Keramat¹⁴, Denise Brookes¹⁴, Roslyn N Boyd²

Affiliations

¹ Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia l.sakzewski1@uq.edu.au.
² Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia.
³ School of Allied Health, Curtin University, Perth, Western Australia, Australia.
⁴ Telethon Kids Institute, Nedlands, Western Australia, Australia.
⁵ School of Health and Rehabilitation Science, The University of Queensland - Saint Lucia Campus, Saint Lucia, Queensland, Australia.
⁶ Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁷ School of Human Movement and Nutrition Sciences, The University of Queensland, Saint Lucia, Queensland, Australia.
⁸ Children's Health Queensland Hospital and Health Service, South Brisbane, Queensland, Australia.
⁹ School of Physical and Occupational Therapy, McGill University, Montreal, Québec, Canada.
¹⁰ Centre for Health Services Research, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.
¹¹ Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.
¹² Physiotherapy Department, Cairns and Hinterland Hospital and Health Service, Cairns, Queensland, Australia.
¹³ Liggins Institute, The University of Auckland, Auckland, New Zealand.
¹⁴ Child Health Research Centre, Faculty of Medicine, The University of Queensland, South Brisbane, Queensland, Australia.

PMID: 37788925
PMCID: PMC10551958
DOI: 10.1136/bmjopen-2023-075570

Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial

Leanne Sakzewski et al. BMJ Open. 2023.

. 2023 Oct 3;13(10):e075570.

doi: 10.1136/bmjopen-2023-075570.

Authors

Affiliations

¹ Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia l.sakzewski1@uq.edu.au.
² Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia.
³ School of Allied Health, Curtin University, Perth, Western Australia, Australia.
⁴ Telethon Kids Institute, Nedlands, Western Australia, Australia.
⁵ School of Health and Rehabilitation Science, The University of Queensland - Saint Lucia Campus, Saint Lucia, Queensland, Australia.
⁶ Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁷ School of Human Movement and Nutrition Sciences, The University of Queensland, Saint Lucia, Queensland, Australia.
⁸ Children's Health Queensland Hospital and Health Service, South Brisbane, Queensland, Australia.
⁹ School of Physical and Occupational Therapy, McGill University, Montreal, Québec, Canada.
¹⁰ Centre for Health Services Research, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.
¹¹ Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.
¹² Physiotherapy Department, Cairns and Hinterland Hospital and Health Service, Cairns, Queensland, Australia.
¹³ Liggins Institute, The University of Auckland, Auckland, New Zealand.
¹⁴ Child Health Research Centre, Faculty of Medicine, The University of Queensland, South Brisbane, Queensland, Australia.

PMID: 37788925
PMCID: PMC10551958
DOI: 10.1136/bmjopen-2023-075570

Abstract

Introduction: Children with cerebral palsy (CP) participate less in physical activities and have increased sedentary behaviour compared with typically developing peers. Participate CP is a participation-focused therapy intervention for children with CP with demonstrated efficacy in a phase II randomised controlled trial (RCT) to increase perceived performance of physical activity participation goals. This study will test the effectiveness of Participate CP in a multisite phase III RCT.

Methods and analysis: One hundred children with CP, aged 8-14 years, classified Gross Motor Function Classification System levels I-IV will be randomised to either (1) receive Participate CP once/week for 1 hour for 12 weeks, or (2) waitlist control, usual care group. The waitlist group will then receive Participate CP following the 26-week retention time point. Outcomes will be assessed at baseline, 12 weeks and then 26 weeks post baseline. The primary outcomes are (1) self-reported participation goal performance on the Canadian Occupational Performance Measure at 12 weeks and (2) daily time in moderate-to-vigorous physical activity. Secondary outcomes include home and community participation frequency, involvement and environmental supportiveness, contextual barriers to participation, quality of life, intrinsic motivation for physical activities, child perception of an autonomy-supportive climate for physical activities and physical literacy at 12 and 26 weeks post study entry.

Ethics and dissemination: The Children's Health Queensland Hospital and Health Service, The University of Queensland and the New Zealand Health and Disability Ethics Committees have approved this study. Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number: ACTRN12618000206224.

Keywords: clinical trial; developmental neurology & neurodisability; paediatric neurology; physical therapy modalities.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
Consolidated Standards of Reporting Trials study flowchart. CP, cerebral palsy.

See this image and copyright information in PMC

Cited by

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References

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[1] Access Economics . The Economic Impact of Cerebral Palsy in Australia in 2007. 2008.

[2] Access Economics . The Economic Impact of Cerebral Palsy in Australia in 2007. 2008.

[3] Wake M, Salmon L, Reddihough D. Health status of Australian children with mild to severe cerebral palsy: cross-sectional survey using the child health questionnaire. Dev Med Child Neurol 2003;45:194–9. 10.1017/s0012162203000379 - DOI - PubMed

[4] Wake M, Salmon L, Reddihough D. Health status of Australian children with mild to severe cerebral palsy: cross-sectional survey using the child health questionnaire. Dev Med Child Neurol 2003;45:194–9. 10.1017/s0012162203000379 - DOI - PubMed

[5] Peterson MD, Ryan JM, Hurvitz EA, et al. . Chronic conditions in adults with cerebral palsy. JAMA 2015;314:2303–5. 10.1001/jama.2015.11025 - DOI - PMC - PubMed

[6] Peterson MD, Ryan JM, Hurvitz EA, et al. . Chronic conditions in adults with cerebral palsy. JAMA 2015;314:2303–5. 10.1001/jama.2015.11025 - DOI - PMC - PubMed

[7] Imms C, Adair B. Participation Trajectories: impact of school transitions on children and adolescents with cerebral palsy. Dev Med Child Neurol 2017;59:174–82. 10.1111/dmcn.13229 - DOI - PubMed

[8] Imms C, Adair B. Participation Trajectories: impact of school transitions on children and adolescents with cerebral palsy. Dev Med Child Neurol 2017;59:174–82. 10.1111/dmcn.13229 - DOI - PubMed

[9] Michelsen SI, Flachs EM, Uldall P, et al. . Frequency of participation of 8-12-year-old children with cerebral palsy: a multi-centre cross-sectional European study. Eur J Paediatr Neurol 2009;13:165–77. 10.1016/j.ejpn.2008.03.005 - DOI - PubMed

[10] Michelsen SI, Flachs EM, Uldall P, et al. . Frequency of participation of 8-12-year-old children with cerebral palsy: a multi-centre cross-sectional European study. Eur J Paediatr Neurol 2009;13:165–77. 10.1016/j.ejpn.2008.03.005 - DOI - PubMed

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Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial

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Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial

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